AB1326 EFFICACY AND SECURITY OF TNF-A INHIBITORS BIOSIMILARS IN NON INFECTIOUS UVEITIS
Authors: M. Gomez Vargas
Journal: Annals of the Rheumatic Diseases (2022)

Background Biological drugs have become established as an effective therapeutic alternative to non infectious uveitis refractory to the usual treatment. In that sense, expiry of patents for tumor necrosis factor (TNF-a inhibitors) has allowed the development of biosimilars such as Infliximab and Adalimumab; both originals with years of experience in such pathology but with barely no evidence in real life case series of its biosimilars. Objectives To analyze the effectiveness and security of biosimilars of Infliximab and Adalimumab used in uveitis in a third level hospital. Methods Descriptive study based on a retrospective cohort of 40 patients suffering of non infectious uveitis who have received biological treatment with Infliximab and Adalimumab collected over the last 20 years (2000-2021), taking into account the complete substitution of the original for the biosimilar in our hospital in February 2015 and March 2019, respectively. The number of outbreaks during both the years before and after the start of the biological therapy, as well as the number of outbreaks during the year following the switch from the original to the biosimilar, have been analyzed. In that regard, we have studied variables such as visual acuity, presence of macular edema, vitritis and retinal vasculitis, as well as the need for systemic corticosteroids treatment. We have registered minor and major side effects associated with the treatment and the cases that have required a change of drug. Results The average duration of the immunosuppressive therapy previous to the introduction of the biological therapy was 3,15 years with an average frequency of 2,25 outbreaks during the previous years of the start of the biological therapy. Subsequently, 30 patients received treatment with Adalimumab and 10 with Infliximab showing an average of 0,35+- 0,73 outbreaks during the following year of its start. The switch from the original drug to the biosimilar was subsequently performed in 27 patients (25 for Adalimumab and 2 for Infliximab) with an average of 0,2 +-0,5 and 0,12+-0,44 outbreaks during the 12 months following the switch. Most of them (87%) stayed with the concomitant immunosuppressive treatment, being the Methotrexate the most frequently used (55%). No major side effect has been registered during the biological therapy; however a 25% of the patients showed minor side effects, mostly infections. In 11 cases (27,5%) the biosimilar drug had to be switched, in 7 cases due to inefficiency and 4 to poor tolerance, all of them corresponding to Adalimumab biosimilar. In 5 of those cases the switch was back to the original biological therapy while in the 5 remaining it was to Infliximab biosimilar (4) and Tocilizumab. Two cases of suspension of Adalimumab biosimilar due to disease remission should be highlighted. Conclusion According to our experience, the use of biosimilars of Infliximab and Adalimumab in non infectious uveitis is safe. The switch to biosimilars could be considered a feasible therapeutic choice in regards to keeping its effectiveness in patients previously treated with the original drug, even though studies featuring longer follow-up time and more population would be needed. Table 1. BASAL CHARACTERISTICS AGE, mean (SD ) 36,8 (24) Male n (%), Female n (% ) 23 (57,5%), 17 (42,5%) UVEITIS Primary n (% ) 20 (50%) Secundary n(% ) 20 (50%) *Systemic disease association JIA (30%); Behcet (15%); AS (10%); Others (45%) Anterior Uveitis n (% ) 22 (55%) Posterior Uveitis n(% ) 9 (22,5%) Panuveitis n(% ) 9 (22,5%) Acute Uveitis n(% ) 14 (35%) Chronic Uveitis n(% ) 26 (65%) Bilateral Uveitis n(% ) 28 (70%) Unilateral Uveitis n(% ) 12 (30%) ANA Not Performed n(% ) 1 (2,5%) Negative n(% ) 32 (80%) Positive n(% ) 7 (17,5%) HLA B27 4(10%), B51 7 (17,5%), negative 26 (65%) Disclosure of Interests None declared